LTP-001

Novartis has terminated a mid-stage trial of an oral treatment candidate for idiopathic pulmonary fibrosis, the company confirmed to Endpoints News . The Swiss pharma giant axed a Phase 2 study of LTP001 last Thursday, according to the federal trials registry. The study cull was cited as a “sponsor decision.” A spokesperson added the company will “continue to evaluate future potential for IPF.” Investigators were testing the experimental medicine against placebo as a once-daily medicine for patients with IPF, in which lung scarring disrupts breathing and can lead to death within a few years of diagnosis. Some patients in the trial also received one of the two standard-of-care medicines, Roche’s Esbriet and Boehringer Ingelheim’s Ofev, both of which were FDA-approved in 2014. Generic versions of Esbriet are available and Roche confirmed in February it was looking at “potential options for Esbriet,” including a potential sale. Multiple other biotechs are working on potential treatments for IPF, including Pliant , PureTech and Avalyn Pharma . Boehringer is planning to send another IPF medicine, the oral drug nerandomilast, to the FDA for regulatory approval based on Phase 3 results last month. LTP001 is also being studied in pulmonary arterial hypertension, or PAH, a rare lung condition that recently received a key approval with Merck’s Winrevair. PAH impacts about 40,000 people in the US and causes high blood pressure in the lungs and heart. In Novartis’ July earnings presentation, PAH was listed as the lead indication for LTP001. Shortly thereafter, the company ended a placebo-controlled Phase 2 and an extension study of the candidate in PAH. On Monday, the spokesperson reiterated the company continues to advance LTP001 in PAH. “There have been no concerning or new safety signals observed to date,” the spokesperson added. LTP001 is an inhibitor of SMURF1, which has been found to be elevated in pulmonary arteries in animal models. Johnson & Johnson received an FDA green light for a single-tablet combination treatment for PAH earlier this year. Aerovate’s treatment candidate recently flunked a mid-stage test, which led to lay offs . Gossamer Bio and Diagonal Therapeutics are among other biotechs exploring this space.